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Background: A growing number of older adults (ages 65+) live with Type 1 diabetes. Simultaneously, technologies such as continuous glucose monitoring (CGM) have become standard of care. There is thus a need to understand better the complex dynamics that promote use of CGM (and other care innovations) over time in this age group. Our aim was to adapt methods from systems thinking, specifically a participatory approach to system dynamics modeling called group model building (GMB), to model the complex experiences that may underlie different trajectories of CGM use among this population. Herein, we report on the feasibility, strengths, and limitations of this methodology. Methods: We conducted a series of GMB workshops and validation interviews to collect data in the form of questionnaires, diagrams, and recordings of group discussion. Data were integrated into a conceptual diagram of the "system" of factors associated with uptake and use of CGM over time. We evaluate the feasibility of each aspect of the study, including the teaching of systems thinking to older adult participants. We collected participant feedback on positive aspects of their experiences and areas for improvement. Results: We completed nine GMB workshops with older adults and their caregivers (N = 33). Each three-hour in-person workshop comprised: (1) questionnaires; (2) the GMB session, including both didactic components and structured activities; and (3) a brief focus group discussion. Within the GMB session, individual drawing activities proved to be the most challenging for participants, while group activities and discussion of relevant dynamics over time for illustrative (i.e., realistic but not real) patients yielded rich engagement and sufficient information for system diagramming. Study participants liked the opportunity to share experiences with peers, learning and enhancing their knowledge, peer support, age-specific discussions, the workshop pace and structure, and the systems thinking framework. Participants gave mixed feedback on the workshop duration. Conclusions: The study demonstrates preliminary feasibility, acceptability, and the value of GMB for engaging older adults about key determinants of complex health behaviors over time. To our knowledge, few studies have extended participatory systems science methods to older adult stakeholders. Future studies may utilize this methodology to inform novel approaches for supporting health across the lifespan. [ABSTRACT FROM AUTHOR]

Objective (Study Question): To use systems thinking with diverse system actors to (a) characterize current problems at the intersection of chronic conditions (CCs) and reproductive health (RH) care and their determinants, (b) determine necessary system actors for change, and (c) document cross‐system actions that can improve identified problems in the United States. Data Sources/Study Setting: Data were collected from six groups of system actors via online focus groups. Study Design: This is a qualitative multilevel study using the iceberg systems thinking framework. Data Collection/Extraction Methods: Data were collected by note‐taking and recording six focus groups; analysis incorporated perspective triangulation using the systems thinking iceberg and system mapping to visualize interconnected system challenges, actors, and action ideas. Principal Findings: Participants described eight necessary system actors: health care institutions, medical leaders, medical providers, patient advocates and foundations, patients and families, payors, policy makers, and research funders. Forty pain points were identified, spread across each of the four levels of the systems thinking iceberg: undesirable outcomes (6), concerning trends (9), system structure flaws (15), and problematic mental models (10). In response to these pain points, a set of 46 action ideas was generated by participants and mapped into nine action themes: (1) adjust QI metrics, incentives, and reimbursement, (2) bolster RH medical education and training, (3) break down medical silos, (4) enrich patient education, (5) expand the health care team, (6) improve holistic health care, (7) modify research and programmatic funding to prioritize RH and CC, (8) spur innovation for patient visits, and (9) support professional champions and leaders. Conclusions: By embracing system complexity, creating visual maps, and pushing participants to identify actionable strategies for improvement, this study generates a set of specific actions that can be used to address pain points across the multiple system levels that make improving reproductive care for people with CCs so challenging. [ABSTRACT FROM AUTHOR]

The U.S. Food and Drug Administration (FDA) allows patients with serious illnesses to access investigational drugs for "compassionate use" outside of clinical trials through expanded access (EA) Programs. The federal Right-to-Try Act created an additional pathway for non-trial access to experimental drugs without institutional review board or FDA approval. This removal of oversight amplifies the responsibility of physicians, but little is known about the role of practicing physicians in non-trial access to investigational drugs. We undertook semi-structured interviews to capture the experiences and opinions of 21 oncologists all with previous EA experience at a major cancer center. We found five main themes. Participants with greater EA experience reported less difficulty accessing drugs through the myriad of administrative processes and drug company reluctance to provide investigational products while newcomers reported administrative hurdles. Oncologists outlined several rationales patients offered when seeking investigational drugs, including those with stronger health literacy and a good scientific rationale versus others who remained skeptical of conventional medicine. Participants reported that most patients had realistic expectations while some had unrealistic optimism. Given the diverse reasons patients sought investigational drugs, four factors—scientific rationale, risk-benefit ratio, functional status of the patient, and patient motivation—influenced oncologists' decisions to request compassionate use drugs. Physicians struggled with a "right-to-try" framing of patient access to experimental drugs, noting instead their own responsibility to protect patients' best interest in the uncertain and risky process of off-protocol access. This study highlights the willingness of oncologists at a major cancer center to pursue non-trial access to experimental treatments for patients while also shedding light on the factors they use when considering such treatment. Our data reveal discrepancies between physicians' sense of patients' expectations and their own internal sense of professional obligation to shepherd a safe process for patients at a vulnerable point in their care. [ABSTRACT FROM AUTHOR]

Background: The federal Right-to-Try (RTT) Act created an alternate regulatory pathway for preapproval access to investigational drugs. A few studies have examined the experiences of physicians with the Food and Drug Administration's Expanded Access Programs, but to our knowledge, no study has yet to examine their attitudes and experiences toward RTT.Methods: This study explored the views of 21 oncologists at a major cancer center with 3 main sites across the United States using semi-structured interviews and qualitative analysis. Participants were selected to have experience with Expanded Access Programs.Results: Most oncologists had limited familiarity with RTT, and several reported confusion about the legislation, including whether patients have a right to investigational drugs and an obligation for companies to provide them. Although oncologists were interested in decreased regulatory burdens, 3 areas of concern were articulated: lack of safety and oversight, unclear structure and no provision for data collection, and potential heightening of patient expectations. Only 4 oncologists had experience discussing RTT, and none formally attempted to obtain the drug through this mechanism. Participants questioned the practicality of RTT legislation and suggested alternative ways to improve access.Conclusions: The study provides foundational empirical data underlying challenging ambiguities by experienced oncologists familiar with off-trial use of investigational therapeutics and reaffirms the role of physicians and regulatory bodies in mitigating the risks of investigational drugs. Our findings highlight the need for medical centers to inform oncologists about RTT and other preapproval pathways so that they are able to address questions from patients interested in nontrial investigational drugs. [ABSTRACT FROM AUTHOR]

Premature commercialization of unproven stem cell interventions (SCIs) has received significant attention within the regenerative medicine community. Patients considering SCIs may encounter misinformation and seek out guidance from their physicians who are trusted brokers of health information. However, little is known about the perspectives of academic physician specialists toward the SCI industry. The purpose of this study was to capture the attitudes of physician specialists with experience addressing patient questions about unproven SCIs. The authors undertook 25 semi-structured interviews with academic physicians in cardiology, ophthalmology, orthopedics, pulmonology and neurology primarily from one academic center. The authors identified two major themes: concerns and mediators of appropriateness of offering SCIs as therapies to patients. Specialists were generally aware of the industry and reported scientific and commercial concerns, including the scientific uncertainty of SCIs, medical harms to patients, misleading marketing and its impact on patient informed consent and economic harms due to large out-of-pocket costs for patients. All specialists outside of orthopedics voiced that it was inappropriate to be offering SCIs to patients today. These views were informed by previously expressed concerns surrounding safety and properly informing patients, levels of evidence needed prior to offering SCIs therapeutically and desired qualifications for clinicians. Among the specialties, orthopedists reported that under certain conditions, SCIs may be appropriate for patients with limited clinical options but only when safety is adequate, expectations are managed and patients are well informed about the risks and chances of benefit. Most participants expressed a desire for phase 3 studies and Food and Drug Administration approval prior to marketing SCIs, but some also shared the challenges associated with upholding these thresholds of evidence, especially when caring for out-of-option patients. The authors' results suggest that medical specialists are aware of the industry and express several concerns surrounding SCIs but differ in their views on the appropriateness and clinical evidence necessary for offering SCIs currently to patients. Additional educational tools may help physicians with patient engagement and expectation management surrounding SCIs. [ABSTRACT FROM AUTHOR]

Aim: To address the unmet needs of patients interested in regenerative medicine, Mayo Clinic created a Regenerative Medicine Consult Service (RMCS). We describe the service and patient satisfaction. Materials & methods: We analyzed RMCS databases through retrospective chart analysis and performed qualitative interviews with patients. Results: The average patient was older to elderly and seeking information about regenerative options for their condition. Patients reported various conditions with osteoarthritis being most common. Over a third of consults included discussions about unproven interventions. About a third of patients received a clinical or research referral. Patients reported the RMCS as useful and the consultant as knowledgeable. Conclusion: An institutional RMCS can meet patients' informational needs and support the responsible translation of regenerative medicine. [ABSTRACT FROM AUTHOR]

The stem cell preservation industry has grown substantially with private businesses, public hospitals, and academic medical centers considering preserving induced pluripotent stem cells, mesenchymal stem cells, and other cell types of patients and the public in order to potentially use them for stem cell therapy should such an intervention exist in the future. Despite this growth and interest among private firms and academic centers, no study has yet considered the bioethical issues of such platforms. In this article, we explore several ethical and social issues related to the biopreservation of stem cells for future regenerative therapies. We analyze a range of bioethical considerations that public and private institutions should bear in mind as they develop stem cell preservation platforms. These include medical validation of regenerative interventions and their influence on the public understanding of stem cell therapies, the impact of public trust of organizations creating a private, for-profit venture of stem cell preservation, and logistical issues in the governance of the collection including ownership and dispositional authority, informed consent and access, and withdrawal and non-payment. These considerations should be incorporated into current and future stem cell preservation platforms in order to promote the responsible translation of regenerative medicine. [ABSTRACT FROM AUTHOR]